Rubraca (Rucaparib)
PARP Inhibitor for Ovarian Cancer Maintenance Therapy
Rubraca (rucaparib) is a targeted cancer medicine belonging to the PARP inhibitor class. It is used as maintenance treatment for ovarian cancer in adults whose tumour has responded to platinum-based chemotherapy. Rubraca works by blocking the PARP enzyme that cancer cells depend on to repair DNA damage, leading to cancer cell death — particularly in patients with BRCA mutations. This page provides comprehensive, evidence-based information about Rubraca’s uses, dosage, side effects, drug interactions, and storage.
Quick Facts
Key Takeaways
- Rubraca is a PARP inhibitor used as maintenance therapy for ovarian cancer after successful platinum-based chemotherapy.
- The standard dose is 600 mg twice daily (1,200 mg total). Your doctor may adjust the dose based on side effects.
- Regular blood tests (complete blood count) are required before and during treatment to monitor for bone marrow suppression.
- Sun protection is essential during treatment due to increased photosensitivity — use SPF 50+ sunscreen and protective clothing.
- Rubraca must not be taken during pregnancy or breastfeeding, and effective contraception is required during treatment and for 6 months after the last dose.
What Is Rubraca and What Is It Used For?
Rubraca contains the active substance rucaparib and belongs to a class of cancer drugs known as PARP inhibitors (poly(ADP-ribose) polymerase inhibitors). PARP is an enzyme that plays a crucial role in repairing damaged DNA within cells. When cancer cells have defects in other DNA repair mechanisms — particularly those caused by mutations in BRCA1 or BRCA2 genes — they become heavily dependent on PARP for survival.
By blocking the PARP enzyme, Rubraca prevents cancer cells from repairing their DNA. This results in the accumulation of lethal DNA damage, ultimately causing the cancer cells to die. This principle is known as synthetic lethality: while normal cells with intact DNA repair pathways can survive PARP inhibition, cancer cells with BRCA mutations or homologous recombination deficiency (HRD) cannot.
Rubraca is specifically approved for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults. It is used after the cancer has responded (either completely or partially) to platinum-based chemotherapy. Maintenance therapy aims to prevent or delay cancer recurrence by continuing treatment after the initial chemotherapy course has ended.
The ARIEL3 clinical trial — a landmark phase 3 randomised, double-blind, placebo-controlled study — demonstrated that rucaparib significantly prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer. The benefit was observed across all patient subgroups, with particularly robust results in patients with BRCA mutations and those with homologous recombination deficiency.
How PARP Inhibition Works
To understand how Rubraca fights cancer, it helps to understand how cells normally repair their DNA. Every day, our cells sustain thousands of DNA breaks from normal metabolic processes and environmental exposures. Two major repair pathways handle these breaks:
- Base excision repair (BER) — handles single-strand DNA breaks using PARP enzymes
- Homologous recombination (HR) — handles double-strand DNA breaks using BRCA1/2 proteins
In patients with BRCA mutations, the homologous recombination pathway is already defective. When Rubraca also blocks the PARP-dependent repair pathway, the cancer cell loses both repair mechanisms simultaneously, leading to genomic instability and cell death. Normal cells, which have at least one functioning copy of BRCA, can still repair their DNA through homologous recombination and therefore tolerate PARP inhibition much better than the cancer cells.
What Should You Know Before Taking Rubraca?
Contraindications
You should not use Rubraca in the following situations:
- Allergy to rucaparib or any other ingredient in the tablets (see the ingredients section below)
- Breastfeeding — you must not breastfeed while taking Rubraca
If you are unsure whether any of these apply to you, speak with your doctor, pharmacist, or nurse before starting treatment with Rubraca. Your medical team will carefully evaluate your suitability for PARP inhibitor therapy and discuss the potential risks and benefits specific to your situation.
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before or during treatment with Rubraca, particularly about the following important safety considerations:
Your doctor or nurse will perform blood tests to check your blood cell counts:
- Before starting Rubraca treatment
- Every month during treatment
- Weekly if blood counts remain low for an extended period
Rubraca can cause low levels of red blood cells, white blood cells, or platelets. Signs and symptoms of low blood counts include fever, infection, bruising, or bleeding. In rare cases, low blood counts may indicate a serious bone marrow problem such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may test your bone marrow to investigate any persistent abnormalities. Treatment with Rubraca may need to be paused until your blood counts improve.
Rubraca can increase your sensitivity to sunlight (photosensitivity), making you more susceptible to sunburn. During treatment, you should:
- Avoid direct sunlight and do not use sunbeds or tanning booths
- Wear protective clothing that covers your head, arms, and legs when outdoors
- Apply sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher
Tell your doctor if you experience nausea, vomiting, diarrhoea, or abdominal pain, as these may be signs that Rubraca is affecting your stomach or intestines. Your doctor can prescribe supportive medications and may adjust your Rubraca dose if gastrointestinal side effects become problematic.
Children and adolescents: Rubraca should not be given to children and adolescents under 18 years of age, as it has not been studied in this age group.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Rubraca requires careful consideration regarding reproductive health:
- Pregnancy: Rubraca is not recommended during pregnancy, as it may harm the unborn child. A pregnancy test is recommended before starting treatment.
- Breastfeeding: Do not breastfeed during treatment with Rubraca and for 2 weeks after the last dose, as it is unknown whether rucaparib passes into breast milk.
- Contraception: Women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose of Rubraca. Discuss the most effective contraceptive method with your doctor or pharmacist.
Driving and Operating Machinery
Rubraca may affect your ability to drive or operate tools and machinery. Exercise caution if you feel tired (fatigued) or experience nausea or dizziness while taking this medicine. These are very common side effects that may impair your reaction time and concentration. If affected, do not drive until symptoms resolve.
This medicine contains less than 1 mmol (23 mg) sodium per tablet, meaning it is essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Rubraca Interact with Other Drugs?
Rucaparib can affect the way other medicines work, and other medicines can affect how Rubraca works. It is crucial to inform your doctor, pharmacist, or nurse about all medicines you are currently taking, have recently taken, or might take. Drug interactions may increase the risk of side effects or reduce the effectiveness of either Rubraca or the co-administered medication.
Rucaparib is metabolised by CYP enzymes and also acts as a moderate inhibitor of CYP1A2, CYP2C9, CYP2C19, and CYP3A4. It also inhibits the transporters P-gp, BCRP, MATE1, MATE2-K, OCT1, and OCT2. These pharmacological properties mean that rucaparib has the potential to interact with a wide range of drugs that are substrates of these enzymes and transporters.
Major Interactions
The following drug classes have clinically significant interactions with Rubraca and may require dose adjustment, additional monitoring, or avoidance of concomitant use:
| Drug / Drug Class | Examples | Interaction Effect | Clinical Action |
|---|---|---|---|
| Anticoagulants | Warfarin | Increased anticoagulant effect via CYP2C9 inhibition | Monitor INR more frequently; dose adjustment may be needed |
| Anticonvulsants | Phenytoin | Increased phenytoin levels via CYP2C19 inhibition | Monitor phenytoin levels; dose reduction may be required |
| Immunosuppressants | Ciclosporin, sirolimus, tacrolimus | Increased immunosuppressant levels via CYP3A4 inhibition | Therapeutic drug monitoring recommended; dose adjustment likely |
| Opioid analgesics | Alfentanil, fentanyl | Increased opioid levels and risk of respiratory depression | Use with caution; monitor for excessive sedation and respiratory depression |
| Ergot alkaloids | Dihydroergotamine, ergotamine | Increased risk of ergot toxicity via CYP3A4 inhibition | Avoid concomitant use if possible |
| Antipsychotics | Pimozide | Increased pimozide levels and risk of QT prolongation | Avoid concomitant use; risk of serious cardiac arrhythmia |
Minor Interactions
The following drugs may also interact with Rubraca, though the clinical significance may be lower. Your doctor will assess the risks and benefits of concomitant use:
| Drug / Drug Class | Examples | Interaction Effect | Clinical Action |
|---|---|---|---|
| Statins | Rosuvastatin | Increased statin levels via BCRP inhibition | Monitor for muscle pain and elevated CK levels |
| Proton pump inhibitors | Omeprazole | Altered metabolism via CYP2C19 interaction | Monitor for gastrointestinal symptoms |
| Antidiabetics | Metformin | Increased metformin levels via MATE1/MATE2-K/OCT2 inhibition | Monitor blood glucose; consider dose adjustment |
| Cardiac glycosides | Digoxin | Increased digoxin levels via P-gp inhibition | Monitor digoxin levels and cardiac function |
| Benzodiazepines | Midazolam | Increased sedation via CYP3A4 inhibition | Monitor for excessive sedation; consider dose reduction |
| Xanthines | Theophylline | Increased theophylline levels via CYP1A2 inhibition | Monitor theophylline levels; dose adjustment may be needed |
| Muscle relaxants | Tizanidine | Significant increase in tizanidine levels via CYP1A2 inhibition | Avoid concomitant use; risk of excessive hypotension and sedation |
| Antiarrhythmics | Quinidine | Altered quinidine levels | Monitor cardiac rhythm and drug levels |
This list is not exhaustive. Always carry an up-to-date list of all your medications — including prescription drugs, over-the-counter products, vitamins, and herbal supplements — and share it with every healthcare professional involved in your care. Your oncologist can provide specific guidance about potential interactions with your individual medication regimen.
What Is the Correct Dosage of Rubraca?
Always take this medicine exactly as your doctor or pharmacist has instructed. If you are unsure about your dose or schedule, check with your doctor, pharmacist, or nurse. The dosage regimen is designed to maintain consistent drug levels in your body throughout the day for optimal anti-cancer activity.
Adults
Standard Dosage
The recommended starting dose is 600 mg twice daily, for a total daily dose of 1,200 mg. This is achieved by taking three 200 mg tablets (or the equivalent combination of available strengths) twice daily.
- Take your first dose in the morning
- Take your second dose in the evening, approximately 12 hours later
- Tablets may be taken with or without food
- Swallow tablets whole with water
Dose Reductions
If you experience certain side effects, your doctor may recommend a lower dose or temporarily pause your treatment. The typical dose reduction steps are:
- First reduction: 400 mg twice daily (800 mg total per day)
- Second reduction: 300 mg twice daily (600 mg total per day)
Do not adjust your dose yourself. Your doctor will determine whether a dose modification is appropriate based on your blood test results and clinical assessment. Rubraca is available in 200 mg, 250 mg, and 300 mg tablets to allow for flexible dosing.
Children
Rubraca is not indicated for use in children and adolescents under 18 years of age. The safety and efficacy of rucaparib have not been established in paediatric patients. Ovarian cancer is extremely rare in children and there are no clinical data supporting the use of PARP inhibitors in this population.
Elderly
No dose adjustment is required based on age alone. Clinical trials included patients over 65 years, and the safety profile was generally consistent with that observed in younger adults. However, elderly patients may be more susceptible to certain side effects such as fatigue and bone marrow suppression, and more frequent blood monitoring may be advisable. Your doctor will tailor the treatment approach based on your overall health status and any age-related organ function changes.
Missed Dose
If you forget to take a dose of Rubraca:
- Skip the missed dose entirely
- Take your next dose at the regular scheduled time
- Do not take a double dose to make up for the forgotten one
If you vomit after taking Rubraca, do not take an additional dose. Simply take your next dose at the usual time. Consistent adherence to your dosing schedule is important for maintaining therapeutic drug levels, so try to establish a daily routine (such as taking your doses with breakfast and dinner) to help you remember.
Overdose
If you take more tablets than prescribed, contact your doctor, pharmacist, or nurse immediately. You may require medical attention. There is no specific antidote for rucaparib overdose; treatment would be supportive and based on your symptoms. Bring your medication packaging with you if you seek emergency medical care, so that healthcare providers can identify exactly what you have taken.
It is important to continue taking Rubraca every day for as long as your doctor has prescribed. Do not stop taking the medicine without first talking to your doctor, even if you feel well. Stopping treatment prematurely may allow the cancer to progress. If you have concerns about side effects or your treatment, discuss them with your oncology team so they can help manage any issues while keeping you on the most effective therapy possible.
What Are the Side Effects of Rubraca?
Side effects are grouped below by how frequently they occur. Not everyone experiences side effects, and many can be managed effectively with supportive care from your medical team. It is important to report any new or worsening symptoms to your doctor promptly, as early intervention often allows treatment to continue with dose adjustments rather than discontinuation.
Contact your doctor immediately if you notice any of the following — you may need urgent treatment:
- Shortness of breath, extreme tiredness, pale skin, or rapid heartbeat (signs of anaemia)
- Bleeding or bruising that lasts longer than usual (signs of thrombocytopenia)
- Fever or signs of infection (signs of neutropenia)
Very Common
- Nausea
- Fatigue and tiredness
- Anaemia (low red blood cells)
- Vomiting
- Abdominal pain
- Taste changes (dysgeusia)
- Elevated liver enzymes (in blood tests)
- Loss of appetite
- Diarrhoea
- Elevated blood creatinine levels
- Shortness of breath (dyspnoea)
- Thrombocytopenia (low platelets)
- Neutropenia (low white blood cells)
- Dizziness
- Photosensitivity (increased sunburn risk)
- Heartburn (dyspepsia)
- Elevated cholesterol
- Rash
Common
- Dehydration
- Itching (pruritus)
- Allergic reaction (e.g. facial or eye swelling)
- Palmar-plantar erythrodysaesthesia (redness, swelling, and pain on palms and/or soles)
- Red spots on the skin (petechiae)
- Bowel obstruction
- Mouth ulcers (stomatitis)
- Myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) — serious bone marrow disorders
Managing Common Side Effects
Many of the common side effects of Rubraca can be managed with supportive care. Your oncology team can recommend strategies to help you cope:
- Nausea and vomiting: Anti-nausea medications (antiemetics) can be prescribed. Eating smaller, more frequent meals and avoiding strong odours may also help.
- Fatigue: Light physical activity, adequate rest, and pacing your daily activities can help manage cancer-related fatigue. Report severe fatigue to your doctor, as it may indicate anaemia requiring treatment.
- Anaemia: Your doctor may recommend iron supplements, blood transfusions, or dose reductions depending on the severity. Eating iron-rich foods (lean red meat, legumes, dark leafy greens) may provide additional support.
- Diarrhoea: Stay well hydrated and speak with your doctor about antidiarrhoeal medications. Report persistent diarrhoea, as it can lead to dehydration and electrolyte imbalances.
- Photosensitivity: Apply SPF 50+ sunscreen daily, even on cloudy days. Wear protective clothing, wide-brimmed hats, and sunglasses when outdoors.
Reporting Side Effects
It is important to report suspected side effects after the medicine has been authorised. This enables continuous monitoring of the medicine’s benefit-risk balance. Healthcare professionals and patients can report suspected adverse reactions to their national medicines agency. In the EU, reports can be submitted through the national reporting systems; in the US, through the FDA MedWatch programme; and in the UK, through the Yellow Card Scheme.
How Should You Store Rubraca?
Proper storage of medication is essential to maintain its effectiveness and safety. Follow these guidelines for storing Rubraca:
- Keep out of sight and reach of children at all times
- Check the expiry date printed on the bottle and carton (after “EXP”). The expiry date refers to the last day of the stated month. Do not use the medicine after this date.
- No special storage conditions are required — store at normal room temperature
- Keep tablets in the original container to protect from environmental factors
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. These measures help protect the environment and prevent accidental exposure.
If you notice any change in the appearance of your tablets (discolouration, crumbling, or unusual odour), do not take them and consult your pharmacist for a replacement supply. While Rubraca does not require refrigeration or protection from light under normal conditions, avoid storing it in extremely hot or humid environments such as bathrooms or near kitchen sinks.
What Does Rubraca Contain?
Active Ingredient
Each Rubraca film-coated tablet contains rucaparib camsylate, equivalent to the stated dose of rucaparib:
- Rubraca 200 mg: rucaparib camsylate equivalent to 200 mg rucaparib
- Rubraca 250 mg: rucaparib camsylate equivalent to 250 mg rucaparib
- Rubraca 300 mg: rucaparib camsylate equivalent to 300 mg rucaparib
Inactive Ingredients
The other ingredients (excipients) in Rubraca tablets include:
Tablet core: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, and magnesium stearate.
Film coating:
- 200 mg tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133), and indigo carmine aluminium lake (E132)
- 250 mg tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b)
- 300 mg tablets: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), and yellow iron oxide (E172)
Tablet Appearance and Packaging
The different strengths of Rubraca tablets can be identified by their distinct shapes and markings:
| Strength | Colour | Shape | Imprint |
|---|---|---|---|
| 200 mg | Blue | Round | C2 |
| 250 mg | White | Diamond (rhombus) | C25 |
| 300 mg | Yellow | Oval | C3 |
Rubraca is supplied in plastic bottles, each containing 60 film-coated tablets. Ensure that you receive the correct strength when collecting your prescription. If you are unsure about the appearance of your tablets, compare them with the descriptions above or ask your pharmacist to verify.
Frequently Asked Questions
Rubraca (rucaparib) is a PARP inhibitor used as maintenance treatment for ovarian cancer in adults. It is prescribed after platinum-based chemotherapy has successfully shrunk the tumour. By blocking the PARP enzyme that cancer cells rely on for DNA repair, Rubraca helps prevent or delay cancer recurrence. It is particularly effective in patients whose tumours carry BRCA gene mutations, though it can benefit broader patient populations with homologous recombination deficiency (HRD).
The most common side effects of Rubraca (affecting more than 1 in 10 patients) include nausea, fatigue, anaemia (low red blood cells), vomiting, abdominal pain, taste changes, elevated liver enzymes, loss of appetite, diarrhoea, elevated creatinine levels, shortness of breath, dizziness, increased sensitivity to sunlight, heartburn, elevated cholesterol, and rash. Haematological side effects (anaemia, thrombocytopenia, neutropenia) are particularly important and require regular blood monitoring.
Yes, Rubraca can be taken with or without food. There is no specific requirement regarding meals. However, some patients find that taking the tablets with food helps reduce nausea, which is a very common side effect. Take your tablets with a glass of water, approximately 12 hours apart (e.g., morning and evening). Choose a schedule that is easiest for you to remember and maintain consistently.
Rubraca works by blocking PARP enzymes (poly(ADP-ribose) polymerases), which are proteins that help repair single-strand DNA breaks in cells. Cancer cells with BRCA mutations already have defective double-strand DNA repair (homologous recombination). When PARP is also inhibited by Rubraca, cancer cells accumulate overwhelming amounts of DNA damage and cannot survive. Normal cells, which have at least one working copy of BRCA genes, can still repair DNA through homologous recombination and are therefore less affected. This concept is called “synthetic lethality.”
A complete blood count (CBC) is required before starting Rubraca and monthly during treatment. If your blood counts are low, weekly tests may be needed. These tests check for anaemia (low red blood cells), thrombocytopenia (low platelets), and neutropenia (low white blood cells). Low blood counts can occasionally indicate serious bone marrow conditions such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Your doctor may recommend bone marrow testing if abnormalities persist. Treatment may be paused until blood counts recover to safe levels.
No, Rubraca should not be taken during pregnancy as it may harm the developing baby. A pregnancy test is recommended before starting treatment. Women who could become pregnant must use effective contraception during treatment with Rubraca and for at least 6 months after the last dose. Breastfeeding must also be avoided during treatment and for 2 weeks after the last dose. If you discover you are pregnant while taking Rubraca, contact your doctor immediately.
References
This article is based on the following peer-reviewed sources, clinical guidelines, and regulatory documents:
- Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2017;390(10106):1949-1961. doi:10.1016/S0140-6736(17)32440-6
- European Medicines Agency (EMA). Rubraca (rucaparib) — Summary of Product Characteristics. Last updated April 2024.
- U.S. Food and Drug Administration (FDA). Rubraca (rucaparib) Prescribing Information. Reference ID: 5184730.
- Ledermann JA, Pujade-Lauraine E, et al. ESMO Clinical Practice Guidelines: Newly diagnosed and relapsed epithelial ovarian carcinoma. Annals of Oncology. 2023;34(10):833-849.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. Version 1.2024.
- Lord CJ, Ashworth A. PARP inhibitors: Synthetic lethality in the clinic. Science. 2017;355(6330):1152-1158. doi:10.1126/science.aam7344
- World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List. 2023.
- British National Formulary (BNF). Rucaparib monograph. National Institute for Health and Care Excellence (NICE). Updated 2024.
About the Medical Editorial Team
This article was written by the iMedic Medical Editorial Team, a multidisciplinary group of healthcare professionals specialising in oncology, pharmacology, and evidence-based medicine.
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